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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K201314
Device Name Restor3d Utility Wedge
Applicant
Restor3D, Inc.
311 W. Corporation St.
Durham,  NC  27701
Applicant Contact Michaela Pigue
Correspondent
Restor3D, Inc.
311 W. Corporation St.
Durham,  NC  27701
Correspondent Contact Michaela Pigue
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Code
HRS  
Date Received05/18/2020
Decision Date 06/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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